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

Inclusion Criteria:

1. Age 22 - 70 years

2. Likely suffer moderate to severe OSA based on history and physical or have anestablished diagnosis of moderate to severe OSA (AHI ≥ 15) based on a prior sleepstudy. PSG will be performed after enrollment, or an acceptable PSG performed within 3 months of enrollment is required, to verify a) AHI ≥ 15 b) mixed and centralapneas total ≤ 25% of apneas, and c) SpO2 must be ≥ 70% for ≥ 90% of sleep time forcontinued eligibility.

3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) orMandibular Advancement Device (MAD)

4. BMI of ≤ 40 kg/m2 at enrollment

5. Is geographically stable and in close proximity to the site

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

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

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

5. Oral cancer or non-healing oral wounds

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

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

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

9. History of cold urticaria

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

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

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

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

14. Active, severe pulmonary vascular disease (for example pulmonary arterialhypertension or pulmonary embolism)

15. Untreated, active thyroid disease such as Hashimoto Thyroiditis that may causeangioedema or enlargement of the tongue

16. History of angioedema of the tongue

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

18. 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

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

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

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

22. Current smoker (≥ 1 pack/day)

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

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

25. Known active substance use disorder

26. 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

27. 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)

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

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

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

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