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

Model Number	FAS3100000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Recurrence after cryoablation treatment.

• Common Device Name: PROSESNE CRYOABLATION SYSTEM
• Manufacturer (Section D): ICECURE MEDICAL LTD; 7 haeshel st.; pob3163; caesarea, isr 30795 04; IS 3079504
• Manufacturer (Section G): ICECURE MEDICAL LTD; 7 haeshel st.; pob3163; caesarea, isr 30795 04; IS 3079504
• Manufacturer Contact: maayan levi ; 7 haeshel st.; pob3163; caesarea, isr 30795-04 ; IS 3079504
• MDR Report Key: 23757016
• Report Number: 3008797959-2025-00011
• Device Sequence Number: 18679553
• Product Code: GEH
• UDI-Device Identifier: 07290015487160
• UDI-Public: 07290015487160
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FAS3100000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2020
• 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: Other
• Patient Sex: Unknown