ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

Inclusion Criteria: * Patient is above 18 years old. * Patient has breast fibroadenoma, proven by biopsy (Core Biopsy). * Patient's fibroadenoma can be visualized with ultrasound. * Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension. * Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure. * The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization. Exclusion Criteria: * Patients with history of breast cancer. * Women with known pregnancy. * Patients with superficial fibroadenoma very close to the skin. * Patient has undergone major surgery within the previous 12 weeks. * Patients with any terminal illness, or with a life expectancy \<2 year. * Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS. * Patient participating in other trials using drugs or devices.