Continued Access Protocol

1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter
System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the
continuous survival of subjects free from one or more primary safety outcome
measures—Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events
(MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or
more Atrial Fibrillation Drugs (AFDs).

2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation
Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing
the continuous survival of subjects with success in the primary effectiveness outcome
measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial
fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation
Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter
System used in the PS-023 STOP AF Pivotal Trial.

Inclusion Criteria:

Subjects must fulfill ALL of the following criteria:

1. Documented PAF:

- diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General
Protocol Terminology), AND

- 2 or more episodes of AF during the 3 months preceding the Consent Date, at least
1 of which must be documented with a tracing

2. 18 and 75 years of age

3. Failure for the treatment of AF (effectiveness or intolerance) of one or more of the
following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or
dofetilide.

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

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. Any woman without freedom from pregnancy as demonstrated by one or more of the
following conditions:

- negative β-HCG test within 7 days prior to Start Date

- history of surgical sterilization

- postmenopausal and free of menses for at least 12 months.

28. Life expectancy less than one (1) year

29. Current or anticipated participation in any other clinical trial of a drug, device or
biologic during the duration of this study

30. Unwilling or unable to comply fully with study procedures and follow-up