MAUDE Adverse Event Report: ICECURE MEDICAL LTD.; PROSESNE CRYOABLATION SYSTEM

Model Number	FAS3100000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent lung cryoablation procedure.During the second probe insertion/positioning, a mild pneumothorax occurred intra-procedurally.The physician assessed the event as a non-serious, mild adverse event with no evidence of device malfunction or deficiency.The event aligns with known risks of lung cryoablation procedures described in the device labeling and user manual, and the complaint will continue to be monitored for trends.

• Common Device Name: PROSESNE CRYOABLATION SYSTEM
• Manufacturer (Section D): ICECURE MEDICAL LTD.; 7 haeshel st.; caesarea, isr 3079504 POB31 63; IS POB3163
• Manufacturer (Section G): ICECURE MEDICAL LTD.; 7 haeshel st.; caesarea, isr 3079504 POB31 63; IS POB3163
• Manufacturer Contact: maayan levi ; 7 haeshel st.; caesarea, isr 3079504 POB31-63 ; IS POB3163
• MDR Report Key: 25196270
• Report Number: 3008797959-2026-00001
• Device Sequence Number: 18744204
• Product Code: GEH
• UDI-Device Identifier: 07290015487160
• UDI-Public: 07290015487160
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K183213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FAS3100000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/17/2026
• Date Device Manufactured: 12/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown