Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea

Inclusion Criteria:

1. To participate in this study, the subject must meet ALL of the following inclusioncriteria:

2. Age 22 - 70 years

3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) orMandibular Advancement Device (MAD) if using, must be < 4 hours per night, < 5days/week.

4. Failed, are not candidates for, or have refused other invasive procedures such ashypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSAsuch as Tirzepatide.

ARCTIC-3, Protocol 11515 Page 75 of 78 5. BMI ≥30 or ≤ 40 kg/m2 at enrollment 6. AHI ≥30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of ≥ 30 at enrollment based on in-lab polysomnography study Is geographically stable and in close proximity to the site 7. Able and willing to provide written consent to participate in the study

Exclusion Criteria:

1. Contraindication to general anesthesia or in the opinion of the Investigator wouldnot be able to tolerate the procedure, including intubation during the procedure orin response to an adverse event

2. Actively taking ACEs/ARBs

3. Actively undergoing immunotherapy (Allergy shots)*, or unwilling to washout ofallergy shots at least 2 weeks prior to study procedure.

• Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-outprior to the study procedure

4. Severe uncontrolled asthma

5. Severe maxillary mandibular insufficiency that in the opinion of the investigatorthought to be the primary cause of OSA

6. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)

7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissueof the upper airway (e.g., uvula, soft palate, or tonsils).

8. Oral cancer or non-healing oral wounds

9. Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nervestimulation.

10. History of radiation therapy to neck or upper respiratory tract

11. Surgical resection for cancer or congenital malformations in the larynx, tongue, orthroat (with exception of tonsillectomy and/or adenoidectomy)

12. History presence of cold urticaria at the time of screening History ofcryoglobulinemia

13. History of allergy to glycerin

14. History of hospitalization with mechanical ventilation due to COVID-19 perinvestigator discretion

15. Resistant hypertension defined as a blood pressure that remains above goal despiteconcurrent use of three antihypertensive agents of different classes taken atmaximally tolerated doses

16. Patients with diagnosed autoimmune disorders including thyroid disease, lupus,multiple myeloma, chronic lymphocytic leukemia

17. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis,muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy orcerebrovascular accident)

18. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)

19. Active, severe pulmonary vascular disease (for example pulmonary arterialhypertension or pulmonary embolism) History of angioedema of the airway

20. Hereditary angioedema and other autoimmune disorders that could lead to acquiredangioedema - confirmed with a compliment component C4 blood test <13mg/dL.

21. Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin DependentDiabetes Mellitus [IDDM]) with HbA1c >9.

22. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA ClassIII or IV heart failure, unstable angina or recent (< 12 months) myocardialinfarction or severe cardiac arrhythmias

23. Subjects with bleeding event, known bleeding diathesis, impaired immunity for anyreason, or heart attack or stroke within the last 12 months

24. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis orexpected to institute dialysis within 6 months

25. History or current clinical evidence of TIA or stroke or muscular dysfunction

26. Current smoker (≥ 1 pack/day)

27. Presence of occupational shift work or anticipation of shift changes during the next 2 years

28. Subject has sleep hygiene behavior that is likely to interfere with measurementoutcomes during PSG and/or HSAT

29. Known active substance use disorder

30. Other severe sleep disorders that in the opinion of the investigator, confoundfunctional assessments of sleepiness such as narcolepsy with cataplexy, severeinsomnia/insomnia secondary to chronic pain, PTSD

31. Patients taking any of the following medication that could affect study endpoints:benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi,Provigil, and Nuvigil)

32. Active psychiatric disease (psychotic illness, major depression, or acute anxietyattacks) which prevents subject's ability to meet study requirements and ability toprovide study consent

33. Females who are pregnant or females of childbearing age with intention to becomepregnant during the study period (≤ 3 months from treatment date)

34. Any other reason the investigator deems subject is unfit for participation in thestudy

35. Subject currently participating in other premarket investigational studies unlessapproved by Sponsor in writing