Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

Inclusion Criteria:

1. Male or female, 18 years and above.

2. A confirmed diagnosis of any cerebral or spinal condition, at least 6 months beforeScreening, resulting in spasticity of the muscles controlling the shoulder andelbow.

3. Not on oral medications for spasticity management or if on any oral medications, theoral medication taken chronically for spasticity management (eg, oral baclofen) mustbe maintained at a stable dose for at least 4 weeks before screening for the study.

4. Not on an intrathecal baclofen pump or if on an intrathecal baclofen pump forspasticity management, must be maintained at a stable dose for six months or morebefore screening for the study.

5. Must have a score on the Modified Ashworth Scale of 2 or more in the targeted area (shoulder and elbow) at Screening and at Baseline (Day-1 pretreatment).

6. A diagnostic nerve block using lidocaine (1% lidocaine, 2 to 3 mL per target nerve)showing a positive response (at least one point reduction from the screeningModified Ashworth Scale score for elbow extension and shoulder abduction) to thetargeted nerves, should be performed within 30 days to at least 6 hours before studytreatment. The diagnostic nerve block effect must be completely resolved beforepretreatment evaluation and the study treatment.

7. Subject, in the investigator's opinion, will not be exposed to unacceptable risk byparticipation.

8. Able to provide informed consent, adhere to the study schedule, and complete allstudy assessments.

Exclusion Criteria:

1. History of stroke, traumatic brain injury, and/or spinal cord injury in less than 6months.

2. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, orRaynaud's disease.

3. History of neurotoxin injections within the past 3 months.

4. Previous injection with phenol or ethyl alcohol at any time in the target areas (shoulder or elbow).

5. Previous surgical intervention that altered the target neuroanatomy of the upperlimb.

6. Current or planned enrollment in an investigational drug or device study for themanagement of spasticity for the duration of the study.

7. Medical instability that interferes with tolerability to spasticity treatment withthe study device as per the investigator's discretion.

8. Any hospitalization within 4 weeks before Screening

9. Diagnosis of amyotrophic lateral sclerosis or any lower motor neuron conditions

10. Allergy or intolerance to amide local anesthetics.

11. Any skin condition in or around the target area that, in the opinion of theinvestigator, could adversely impact treatment.

12. Currently pregnant, nursing, or planning to become pregnant during the study.

13. History of, suspected, or known addiction to or abuse of illicit drug(s),prescription medicine(s), or alcohol within the past 2 years.

14. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in theopinion of the investigator, could interfere with study assessments or compliance.

15. Subject, in the opinion of the investigator, is not a suitable candidate for studyparticipation (eg, history of multiple missed office visits, any related upper limbinjury).

16. Subject is unable to adhere to the assessment schedule.