Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

Safety and effectiveness will be evaluated against pre-specified performance criteria as
determined by the sponsor and FDA. The criteria set in this study have been previously used
to demonstrate safety and effectiveness in cryoablation and radio-frequency ablation for the
treatment of paroxysmal atrial fibrillation.

The analyses of the primary effectiveness objective will take place once all the subjects
with a study cryoablation procedure attempt have reached 36 months of follow-up
post-cryoablation procedure. The analysis of the primary safety objective will take place
once all the subjects with a study cryoablation procedure attempt have reached 12 months of
follow-up post-cryoablation procedure. The analyses for the secondary objectives will take
place once all subjects with a study cryoablation attempt have reached 36 months of follow-up
post-cryoablation procedure.

Inclusion Criteria:

1. Documented PAF:

- Diagnosis of paroxysmal atrial fibrillation (PAF), AND

- 2 or more episodes of AF during the 3 months preceding the consent Date, AND

- At least 1 episode of AF documented with a tracing within 12 months preceding the
consent date.

2. Age 18 years or older

3. Failure for the treatment of AF (effectiveness or intolerance) of at least one
membrane active AAD for rhythm control.

Exclusion Criteria:

1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)

2. Any previous LA surgery

3. Current intracardiac thrombus (can be treated after thrombus is resolved)

4. Presence of any pulmonary vein stents

5. Presence of any pre-existing pulmonary vein stenosis

6. Pre-existing hemidiaphragmatic paralysis

7. Anteroposterior LA diameter > 5.5 cm by TTE

8. Presence of any cardiac valve prosthesis

9. Clinically significant mitral valve regurgitation or stenosis

10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during
the 3 month interval preceding the Consent Date

11. Unstable angina

12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent
Date

13. Any significant congenital heart defect corrected or not (including atrial septal
defects or pulmonary vein abnormalities but not including minor PFO)

14. NYHA class III or IV congestive heart failure

15. Left ventricular ejection fraction (LVEF) < 40%

16. 2º (Type II) or 3º atrioventricular block

17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or
any type of implantable cardiac defibrillator (with or without biventricular pacing
function)

18. Brugada syndrome

19. Long QT syndrome

20. Arrhythmogenic right ventricular dysplasia

21. Sarcoidosis

22. Hypertrophic cardiomyopathy

23. Known cryoglobulinemia

24. Uncontrolled hyperthyroidism

25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month
interval preceding the Consent Date.

26. Any woman known to be pregnant

27. Life expectancy less than one (1) year

28. Current or anticipated participation in any other clinical trial of a drug, device or
biologic during the duration of this study not pre-approved by Medtronic

29. Unwilling or unable to comply fully with study procedures and followup