BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSESNE CRYOABLATION SYSTEM

    MDR report key: 23664071 · Received November 27, 2025

    Report

    Report Number
    3008797959-2025-00010
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 27, 2025
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    RECURRENCE AFTER CRYOABLATION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949206 PROSESNE CRYOABLATION SYSTEM PROSESNE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other